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Found 3 results
510(k) Data Aggregation
K Number
K133302Device Name
FLEXMAP 3D
Manufacturer
LUMINEX CORP.
Date Cleared
2014-01-10
(77 days)
Product Code
NSU
Regulation Number
862.2570Why did this record match?
Applicant Name (Manufacturer) :
LUMINEX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Luminex® FLEXMAP 3D® system with xPONENT® software is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.
Device Description
Not Found
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K Number
K121399Device Name
LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
Manufacturer
LUMINEX CORP.
Date Cleared
2013-01-09
(245 days)
Product Code
NSU
Regulation Number
862.2570Why did this record match?
Applicant Name (Manufacturer) :
LUMINEX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Luminex® FLEXMAP 3D® system with xPONENT® software version 4.0 SP1 is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.
Device Description
Not Found
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K Number
K073506Device Name
LUMINEX LX 100/200 INSTRUMENT
Manufacturer
LUMINEX CORP.
Date Cleared
2008-03-07
(85 days)
Product Code
NSU
Regulation Number
862.2570Why did this record match?
Applicant Name (Manufacturer) :
LUMINEX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Luminex LX 100/200 Instrument is a clinical multiplex test system intended to measure and sort multiple signals generated in an In Vitro Diagnostic assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals.
Device Description
The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals.
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